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151. Endoscopic choledochoduodenostomy by lumen-apposing metal stent in jaundice recurrence after transpapillary metal stent placement.

Author

Anderloni A, Fugazza A, Pellegatta G, Troncone E, Attardo S, Cappello A, and Repici A

Subjects
Aged, 80 and over, Female, Humans, Jaundice, Obstructive etiology, Jaundice, Obstructive pathology, Male, Recurrence, Choledochostomy, Endoscopy, Jaundice, Obstructive surgery, Stents
Abstract

Competing Interests: None

Published
2019
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152. Dual flexible endoscopic rendezvous approach for management of a Zenker's diverticulum with complete esophageal obstruction.

Author

Fugazza A, Cappello A, Maselli R, Belletrutti P, Galtieri A, Pellegatta G, and Repici A

Subjects
Esophageal Stenosis diagnostic imaging, Humans, Male, Middle Aged, Zenker Diverticulum diagnostic imaging, Esophageal Stenosis etiology, Esophageal Stenosis surgery, Esophagoscopy methods, Zenker Diverticulum complications, Zenker Diverticulum surgery
Abstract

Competing Interests: None

Published
2019
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153. Advancements in the use of manometry and impedance testing for esophageal functional disorders.

Author

Savarino E, Marabotto E, Bodini G, Furnari M, Della Coletta M, Ghisa M, Barberio B, Frazzoni M, De Bortoli N, Zentilin P, Pellegatta G, Tolone S, Ottonello A, and Savarino V

Subjects
Electric Impedance, Esophageal Diseases physiopathology, Esophageal Diseases therapy, Humans, Predictive Value of Tests, Pressure, Prognosis, Deglutition, Esophageal Diseases diagnosis, Esophagus physiopathology, Gastrointestinal Motility, Manometry trends
Abstract

Introduction: The utilization of high-resolution manometry (HRM) has enhanced our understanding and assessment of esophageal motor disorders. Moreover, the combination of impedance technology with HRM (HRIM) has further improved our knowledge of esophageal physiology and the clinical evaluation of dysmotility, thanks to the addition of accurate measurement of bolus transit. Areas covered. This paper provides an overview of current knowledge in the use of HRIM for the study of esophageal functional disorders by reporting mainly the results of many publications and several systematic reviews in this field. Expert opinion. HRIM has represented a relevant improvement in the assessment of esophageal motility and has required the development of new metrics, such as the esophageal impedance integral ratio, the bolus flow time, the nadir impedance pressure and the impedance bolus height, which increase the evaluation of esophageal bolus transit. An extension of impedance is represented by functional lumen imaging probe (FLIP), which determines the biophysical properties and the distensibility of the esophagus and permits to detect contractility patterns not seen on HRM alone. We eagerly wait for a new and fruitful iteration of the Chicago Classification, now in version 3.0, which can cover the ongoing clinical experience of HRIM.

Published
2019
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154. Proton pump inhibitors: use and misuse in the clinical setting.

Author

Savarino V, Marabotto E, Zentilin P, Furnari M, Bodini G, De Maria C, Pellegatta G, Coppo C, and Savarino E

Subjects
Anti-Bacterial Agents administration & dosage, Drug Therapy, Combination, Gastrointestinal Diseases physiopathology, Humans, Practice Patterns, Physicians' standards, Proton Pump Inhibitors administration & dosage, Proton Pump Inhibitors adverse effects, Risk Factors, Gastrointestinal Diseases drug therapy, Prescription Drug Misuse statistics & numerical data, Proton Pump Inhibitors therapeutic use
Abstract

Introduction: The introduction of proton pump inhibitors (PPIs) into clinical practice has greatly improved our therapeutic approach to acid-related diseases for their efficacy and safety. Areas Covered: The following evidence-based indications for PPI use are acknowledged by many scientific societies: treatment of the various forms and complications of gastroesophageal reflux disease, eradication of H. pylori infection in combination with two or more antibiotics, short- and long-term therapy of H. pylori-negative peptic ulcers, healing, and prevention of NSAID/COXIB-associated gastric ulcers, co-therapy with endoscopic procedures to control upper digestive bleeding and medical treatment of Zollinger Ellison syndrome. Expert Commentary: Despite the above well-defined indications, however, the use of PPIs continues to grow every year in both western and eastern countries and the endless expansion of the PPI market has created important problems for many regulatory authorities for two relevant features: the progressive increase of the costs of therapy and the greater potential harms for the patients. The major reasons for the misuse of PPIs are the prevention of gastro-duodenal ulcers in patients without risk factors and the stress ulcer prophylaxis in non-intensive care units, steroid therapy alone, anti-platelet or anti-coagulant treatment in patients without risk of gastric injury and the overtreatment of functional dyspepsia.

Published
2018
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155. Improvement in Waldenström's Macroglobulinemia after Successful Treatment of HCV with Direct-acting Antivirals.

Author

Crespi M, Demarzo MG, Brunacci M, Pellegatta G, Ferrando F, Ballestrero A, Grillo F, Savarino V, and Giannini EG

Subjects
Antiviral Agents therapeutic use, Biopsy, Needle, Drug Therapy, Combination, Female, Follow-Up Studies, Hepatitis C, Chronic complications, Hepatitis C, Chronic pathology, Humans, Immunohistochemistry, Liver Cirrhosis pathology, Middle Aged, Severity of Illness Index, Treatment Outcome, Waldenstrom Macroglobulinemia complications, Waldenstrom Macroglobulinemia pathology, Hepatitis C, Chronic drug therapy, Liver Cirrhosis drug therapy, Liver Cirrhosis virology, Simeprevir therapeutic use, Sofosbuvir therapeutic use, Waldenstrom Macroglobulinemia drug therapy
Abstract

Chronic hepatitis C (HCV) virus infection may be associated with several non-hepatic manifestations, mainly driven by chronic immune stimulation, such as mixed cryoglobulinemia and Non-Hodgkin's Lymphoma. This association has been proved by several meta-analyses and some interventional studies demonstrating that antiviral treatment may be effective in inducing HCV-associated lymphoma regression. The recent advent of direct acting antivirals (DAAs) in the therapeutic armamentarium of HCV infection made possible treatment of patients with advanced liver disease. Here we report on a rare association of a cirrhotic patient with HCV and Waldenström's Macroglobulinemia with severe cryoglobulinemia, who had already failed an interferon-based antiviral regimen, whose haematologic disease was ameliorated by HCV eradication following treatment with sofosbuvir and simeprevir with ribavirin, and where successful treatment was accompanied also by consistent improvement in liver function and parameters of portal hypertension.

Published
2018
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156. The appropriate use of proton-pump inhibitors.

Author

Savarino V, Marabotto E, Zentilin P, Furnari M, Bodini G, De Maria C, Pellegatta G, Coppo C, and Savarino E

Subjects
Anti-Inflammatory Agents, Non-Steroidal adverse effects, Combined Modality Therapy, Drug Therapy, Combination, Esophagitis drug therapy, Evidence-Based Medicine, Gastroesophageal Reflux drug therapy, Helicobacter Infections drug therapy, Histamine H2 Antagonists administration & dosage, Humans, Inappropriate Prescribing, Peptic Ulcer drug therapy, Peptic Ulcer prevention & control, Practice Guidelines as Topic, Prescription Drug Overuse, Proton Pump Inhibitors administration & dosage, Proton Pump Inhibitors adverse effects, Proton Pump Inhibitors economics, Proton Pump Inhibitors therapeutic use
Abstract

The introduction of proton-pump inhibitors (PPIs) into clinical practice since about thirty years has greatly improved our therapeutic approach to acid-related diseases for their well recognized efficacy and safety. Accordingly, the role of surgery has been enormously reduced in this field. The main indications for PPI use are universally acknowledged by many scientific societies and are the following: treatment of gastroesophageal reflux disease in its various forms and complications, eradication of H. pylori infection in combination with two or more antibiotics, therapy of H. pylori-negative peptic ulcers, healing and prevention of NSAID-associated gastric ulcers, co-therapy with endoscopic procedures to control upper digestive bleeding and medical treatment of Zollinger-Ellison Syndrome. Despite the above well-defined indications, however, the use of PPIs continues to grow every year in both Western and Eastern countries and this phenomenon poses serious queries about the appropriate prescription of these drugs worldwide. In fact, the endless expansion of PPI market has created important problems for many regulatory authorities for two relevant features: the progressive and irreversible increase of the costs of therapy with this class of drugs and the greater potential harms for the patients. So, there is the need for a reappraisal of PPI correct indications for both general practitioners and various specialists in order to re-establish a correct use of these effective drugs in daily clinical practice, according to the best evidence-based guidelines.

Published
2018
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157. A safety review of proton pump inhibitors to treat acid-related digestive diseases.

Author

Savarino E, Marabotto E, Zentilin P, Furnari M, Bodini G, Pellegatta G, Lorenzon G, Della Coletta M, Ghisa M, Coppo C, Marinelli C, and Savarino V

Subjects
Animals, Humans, Patient Selection, Proton Pump Inhibitors adverse effects, Research Design, Gastrointestinal Diseases drug therapy, Proton Pump Inhibitors administration & dosage
Abstract

Introduction: Proton pump inhibitors (PPIs) have become the first choice medical treatment of acid-related disease and, as with any pharmacological agent, they have been reported to be associated with some adverse events mainly linked to their chronic use. The most important postulated harms are represented by serum electrolyte alterations, vitamin B12 and iron deficiency, gastric tumors, enteric infections, spontaneous bacterial peritonitis, pneumonia, ischemic heart attacks, bone fractures, chronic kidney disease, dementia, and Alzheimer disease. Specific pathophysiological mechanisms have been identified for some of them and not for other manifestations., Areas Covered: However, studies on PPIs safety have generally important limitations because of their frequent retrospective design and other methodological drawbacks, such as patients' selection and residual confounders., Expert Opinion: Obviously, in the vast majority of the cases, adverse drug reactions cannot be assessed by means of randomized clinical trials due to the high costs, ethical reasons, and difficulties in performing prospective observational studies. So far, assessment of retrospective observational investigations remains the only method to evaluate adverse events with any drug in general and, although the weaknesses of these studies are evident, the awareness of the reported associations with the medications analyzed is important for physicians in order to manage adequately their individual patients.

Published
2018
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158. Correction: Application of the Intermediate-Stage Subclassification to Patients With Untreated Hepatocellular Carcinoma.

Author

Giannini EG, Moscatelli A, Pellegatta G, Vitale A, Farinati F, Ciccarese F, Piscaglia F, Rapaccini GL, Di Marco M, Caturelli E, Zoli M, Borzio F, Cabibbo G, Felder M, Sacco R, Morisco F, Missale G, Foschi FG, Gasbarrini A, Baroni GS, Virdone R, Masotto A, and Trevisani F

Abstract

In the Italian Liver Cancer (ITA.LI.CA) Group, contributor name Alberta Capelli is misspelled and should be corrected to Alberta Cappelli.

Published
2018
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159. Complexity and diversity of gastroesophageal reflux disease phenotypes.

Author

Zentilin P, Marabotto E, Pellegatta G, Coppo C, Furnari M, Savarino E, and Savarino V

Subjects
Esophageal pH Monitoring, Esophagitis, Peptic physiopathology, Gastroesophageal Reflux physiopathology, Heartburn physiopathology, Humans, Phenotype, Gastroesophageal Reflux diagnosis
Abstract

Gastroesophageal reflux disease (GERD) is defined as a condition which develops when the reflux of gastric contents causes troublesome symptoms, impairs quality of life, or leads to mucosal damage or complications. There are two main phenotypic presentations of GERD, the erosive (ERD) and non-erosive reflux disease (NERD), with the latter one representing up to 70% of GERD spectrum. Moreover, patients with GERD can be clinically subdivided into two distinct syndromes: patients with esophageal and extraesophageal symptoms. The diagnosis of NERD should be supported by the evidence that symptoms are due to reflux episodes on the basis of an excess of acid into the esophagus or a positive correlation between symptoms and acid and/or weakly acidic reflux episodes as evidenced by 24-hour impedance-pH monitoring. Patients with normal esophageal acid exposure and no correlation between heartburn and any kind of chemical reflux are considered affected by functional heartburn and do not pertain to the realm of NERD. They do not usually respond to PPI therapy as further empirical criterion and are included in the large group of functional digestive disorders with the expression of altered generation or perception of symptoms at the esophageal level and can often overlap with functional dyspepsia and irritable bowel syndrome.

Published
2017
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160. A review of pharmacotherapy for treating gastroesophageal reflux disease (GERD).

Author

Savarino E, Zentilin P, Marabotto E, Bodini G, Della Coletta M, Frazzoni M, de Bortoli N, Martinucci I, Tolone S, Pellegatta G, and Savarino V

Subjects
Antacids administration & dosage, Antidepressive Agents administration & dosage, Clinical Trials as Topic, Gastroesophageal Reflux physiopathology, Gastrointestinal Motility drug effects, Humans, Mucous Membrane drug effects, Proton Pump Inhibitors administration & dosage, Treatment Outcome, Antacids therapeutic use, Antidepressive Agents therapeutic use, Gastroesophageal Reflux drug therapy, Proton Pump Inhibitors therapeutic use
Abstract

Introduction: Medical therapy of gastroesophageal reflux disease (GERD) is based on the use of proton pump inhibitors (PPIs) as first choice treatment. Despite their effectiveness, about 20-30% of patients report an inadequate response and alternative drugs are required. Areas covered: This review provides an overview of current pharmacotherapy for treating GERD by showing the results of PPIs, reflux inhibitors, antidepressants and mucosa protective medications. Expert opinion: Medical therapy of GERD does not definitely cure the disease, because even PPIs are not able to change the key factors responsible for it. However, they remain the mainstay of medical treatment, allowing us to alleviate symptoms, heal esophagitis and prevent complications in the majority of cases. Nevertheless, many patients do not respond, because acid does not play any pathogenetic role. Prokinetics and reflux inhibitors have the potential to control motor abnormalities, but the results of clinical trials are inconsistent. Antidepressant drugs are effective in specific subgroups of NERD patients with visceral hypersensitivity, but larger, controlled clinical studies are necessary. Protective drugs or medical devices have been recently adopted to reinforce mucosal resistance and preliminary trials have confirmed their efficacy either combined with or as add-on medication to PPIs in refractory patients.

Published
2017
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161. Epidemiology and natural history of gastroesophageal reflux disease.

Author

Savarino E, Marabotto E, Bodini G, Pellegatta G, Coppo C, Giambruno E, Brunacci M, Zentilin P, and Savarino V

Subjects
Barrett Esophagus etiology, Esophagitis, Peptic etiology, Humans, Gastroesophageal Reflux complications, Gastroesophageal Reflux epidemiology
Abstract

Gastroesophageal reflux disease (GERD) is highly prevalent in Western countries, particularly when considering its most classic symptom that is heartburn. This symptom is very frequent in the community and ranges from 10% to more than 30%, according to the various population-based studies. This disease is much more represented in Europe and USA than in Asiatic countries. It has been shown that GERD prevalence increases in parallel with the remarkable growth of obesity, as this condition is able to favor all the pathogenetic mechanisms leading to it. Current information regarding the phenotypic presentation of GERD shows that there are two main phenotypic manifestations, that are erosive reflux disease (ERD) and non-erosive reflux disease (NERD) and the latter includes the majority of patients (up to 70%). The major complication of GERD is the development of Barrett esophagus, a pre-malignant lesion potentially leading to esophageal adenocarcinoma. Data from medical literature on the natural history of this disease are scant and mainly retrospective, so the interpretation of them is very difficult. However, they seem to suggest that both NERD and mild esophagitis tend to remain as such overtime and the progression from NERD to ERD, from mild to severe ERD and from ERD to Barrett's esophagus may occur only in a small number of cases, ranging from 0% to 30%, 10-22% and 1-13%, respectively. Future studies should help us in elucidating better the real transition from one category to another and to do this, we have to exclude from the world of GERD all the functional conditions that nowadays can be easily recognized by means of impedance-pH monitoring.

Published
2017
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163. Drugs for improving esophageal mucosa defense: where are we now and where are we going?

Author

Savarino E, Zentilin P, Marabotto E, Pellegatta G, Coppo C, Brunacci M, Dulbecco P, and Savarino V

Abstract

In the past, the attention of physiologists and doctors has been mainly focused on the key role of acid in the pathogenesis of gastroesophageal reflux disease (GERD), but increasing evidence that 20-40% of reflux patients respond not at all or only partially to proton pump inhibitors (PPIs) has underlined the concept that factors other than acid are implicated in its development and the elicitation of symptoms. Among these, impaired mucosal integrity, particularly in most patients with non-erosive reflux disease, has recently been reincluded and the reinforcement of defensive mechanisms and/or its protection has been reappointed as a renewed therapeutic target for the management of GERD patients. In this review we will summarize the existing knowledge of the old and novel compounds able to produce this therapeutic effect, including sucralfate, alginate-based drugs, and a new medical device consisting of hyaluronic acid and chondroitin sulfate dispersed in a bioadhesive carrier, together with the potential indications for their use. It is to be stressed, however, that, although these compounds may represent a real alternative to PPI therapy in GERD, the combination of mucosal protection with acid suppression may help manage many cases with a partial or unsatisfactory response to PPIs alone., Competing Interests: Conflict of Interest: None

Published
2017
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164. Vonoprazan for treatment of gastroesophageal reflux: pharmacodynamic and pharmacokinetic considerations.

Author

Savarino E, Martinucci I, Furnari M, Romana C, Pellegatta G, Moscatelli A, Bodini G, Marabotto E, Savarino V, de Bortoli N, and Blandizzi C

Abstract

Introduction: About 30-40% of GERD patients report an inadequate response to proton pump inhibitors (PPIs) due to their suboptimal pharmacological profiles. Recently, a new synthesized P-CABs, vonoprazan, showed higher suppression of gastric acid secretion as compared to lansoprazole. Areas covered: This review provides an update on the pharmacokinetic properties of vonoprazan and their correlates with pharmacodynamics; preliminary data on the therapeutic efficacy of vonoprazan as compared to lansoprazole in GERD patients Expert opinion: At variance from all available PPIs, vonoprazan acts directly on H+,K+-ATPase irrespectively of its activity, providing a fast onset of action without requiring acid activation and specific administration timing. Clinical and pharmacological investigations have confirmed a more rapid, potent and prolonged inhibition of acid secretion, including a better nighttime acid control, and a less antisecretory variability, as compared with PPIs. Preliminary data in patients with erosive esophagitis (EE) have shown the non-inferiority of vonoprazan to lansoprazole in terms of symptom relief and healing rate. Since these pharmacokinetic advantages, it is expected that it will have a significant favorable impact on GERD management. However, the clinical use of vonoprazan raises also some issues about its efficacy and safety in the long-term that deserve verification and careful investigation.

Published
2016
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165. Adalimumab trough serum levels and anti-adalimumab antibodies in the long-term clinical outcome of patients with Crohn's disease.

Author

Bodini G, Giannini EG, Savarino V, Del Nero L, Pellegatta G, De Maria C, Baldissarro I, and Savarino E

Subjects
Adalimumab immunology, Adult, Aged, Anti-Inflammatory Agents therapeutic use, Crohn Disease immunology, Drug Monitoring methods, Female, Follow-Up Studies, Humans, Italy, Male, Middle Aged, Prospective Studies, Treatment Outcome, Young Adult, Adalimumab blood, Adalimumab therapeutic use, Anti-Inflammatory Agents blood, Antibodies blood, Crohn Disease blood, Crohn Disease drug therapy
Abstract

Objective: Few data are available on the relevance of adalimumab (ADA) trough serum levels and anti-ADA antibodies (AAA) during long-term follow-up of patients with Crohn's Disease (CD), and their association with disease outcome. In this study, our aim was to assess ADA trough serum levels and the presence of AAA according to disease activity and clinical response during long-term follow-up in a series of patients with CD treated with ADA monotherapy., Material and Methods: We prospectively evaluated 23 consecutive, infliximab-naïve CD patients who achieved clinical remission/response after induction and were in maintenance treatment with ADA, and who were followed-up for at least 72 weeks. Blood samples were drawn at standardized time points to assess ADA through levels, AAA., Results: At week 48, we found significantly (p = 0.027) different ADA trough serum levels in patients in remission (10.1 mcg/mL), mild (7.4 mcg/mL), and moderate/severe disease (4.5 mcg/mL). Median ADA trough levels were significantly lower in patients with AAA (3.7 mcg/mL versus 9.3 mcg/mL, p = 0.006). At the end of follow-up (median 102 weeks, range 73-112 weeks), ADA trough serum concentrations were significantly higher (11.9 mcg/mL) as compared to patients with mild and moderate/severe disease (5.5 mcg/mL, p = 0.0002). Furthermore, median ADA trough concentrations showed a trend towards lower levels in AAA positive patients (5.2 mcg/mL versus 7.2 mcg/mL, p = 0.371)., Conclusions: Our results emphasize the relevance of therapeutic drug monitoring in CD patients on biologic treatment. ADA trough serum levels and the presence of AAA are important features in the management of patients on ADA treatment.

Published
2016
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166. Positive PET in a Patient With Esophageal Leiomyoma.

Author

Nero LD, Moscatelli A, Fazio V, Pellegatta G, Bongioanni F, Sambuceti G, Savarino V, and Giannini EG

Subjects
Adult, Diagnosis, Differential, Esophageal Neoplasms pathology, Esophageal Neoplasms secondary, Esophageal Neoplasms surgery, Fluorodeoxyglucose F18, Humans, Leiomyoma pathology, Leiomyoma surgery, Male, Positron Emission Tomography Computed Tomography, Radiopharmaceuticals, Esophageal Neoplasms diagnostic imaging, Hodgkin Disease pathology, Leiomyoma diagnostic imaging
Published
2016
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167. Application of the Intermediate-Stage Subclassification to Patients With Untreated Hepatocellular Carcinoma.

Author

Giannini EG, Moscatelli A, Pellegatta G, Vitale A, Farinati F, Ciccarese F, Piscaglia F, Rapaccini GL, Di Marco M, Caturelli E, Zoli M, Borzio F, Cabibbo G, Felder M, Sacco R, Morisco F, Missale G, Foschi FG, Gasbarrini A, Baroni GS, Virdone R, Masotto A, and Trevisani F

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Neoplasm Staging, Prognosis, Prospective Studies, Young Adult, Carcinoma, Hepatocellular classification, Carcinoma, Hepatocellular pathology, Liver Neoplasms classification, Liver Neoplasms pathology
Abstract

Objectives: The Barcelona Clinic Liver Cancer (BCLC) intermediate stage (BCLC B) includes a heterogeneous population of patients with hepatocellular carcinoma (HCC). Recently, in order to facilitate treatment decisions, a panel of experts proposed to subclassify BCLC B patients. In this study, we aimed to assess the prognostic capability of the BCLC B stage reclassification in a large cohort of patients with untreated HCC managed by the Italian Liver Cancer Group., Methods: We assessed the prognosis of 269 untreated HCC patients observed in the period 1987-2012 who were reclassified according to the proposed subclassification of the BCLC B stage from stage B1 to stage B4. We evaluated and compared the survival of the various substages., Results: Median survival progressively decreased from stage B1 (n=65, 24.2%: 25 months) through stages B2 (n=105, 39.0%: 16 months) and B3 (n=22, 8.2%: 9 months), to stage B4 (n=77, 28.6%: 5 months; P<0.0001). Moreover, we observed a significantly different survival between contiguous stages (B1 vs. B2, P=0.0002; B2 vs. B3, P<0.0001; B3 vs. B4, P=0.0219). In multivariate analysis, the BCLC B subclassification (P<0.0001), MELD score (P=0.0013), and platelet count (P=0.0252) were independent predictors of survival., Conclusions: The subclassification of the intermediate-stage HCC predicts the prognosis of patients with untreated HCC. The prognostic figures identified in this study may be used as a benchmark to assess the efficacy of therapeutic intervention in the various BCLC B substages, whereas it remains to be established whether incorporation of the MELD score might improve the prognosis of treated patients.

Published
2016
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168. Impact of the COVID-19 pandemic on an interdisciplinary endoscopy unit in a German "hotspot" area: a single center experience.

Author

Wichmann, Dörte, Atique, Naushad Bijoy, Stüker, Dietmar, Fusco, Stefano, Schempf, Ulrike, Grottenthaler, Julia M., Böckeler, Michael, Thiel, Christian, Zender, Lars, Königsrainer, Alfred, Malek, Nisar P., and Werner, Christoph R.

Subjects
*COVID-19, *PANDEMICS, *COVID-19 pandemic, *MEDICAL personnel, *SARS-CoV-2, *ENDOSCOPY, DEVELOPING countries
Abstract

Background and Study Aims: Since December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative pathogen of coronavirus disease 2019 (COVID-19), has posed a pandemic threat to global health and has challenged health care system in all affected countries.Patients and Methods: This is a combined study including a descriptive part about the changes in the daily work routine of an Interdisciplinary Endoscopic Unit (IEU) and a prospective analysis of patients tested positive for SARS-CoV-2 who required endoscopic interventions. Conclusively, we present the finding of a point-prevalence analysis in the staff of the IEU.Results: We present effects of the COVID-19-related restructuring of processes in our interdisciplinary endoscopy unit (IEU) with respect to cancelation of examinations, relocation of staff to other departments, impact of SARS-CoV-2 on medical staff of the IEU, and supply of protective clothing. Additionally, we analyzed the cohort of COVID-19 patients: Sixteen endoscopic interventions were done in ten patients. In all patients with confirmed infection with SARS-CoV-2, emergency endoscopies were required for relevant bleeding situations. Re-endoscopies were required only in critically ill COVID-19 patients.Conclusions: The restructuring of processes in the IEU was feasible in short time, effective, and can also be applied broadly at least in developed countries [Garbe et al. in Gastroenterology 159:778-780, 2020; Repici A, Pace F, Gabbiadini R, Colombo M, Hassan C, Dinelli M, Group IG-CW, Maselli R, Spadaccini M, Mutignani M, Gabbrielli A, Signorelli C, Spada C, Leoni P, Fabbri C, Segato S, Gaffuri N, Mangiavillano B, Radaelli F, Salerno R, Bargiggia S, Maroni L, Benedetti A, Occhipinti P, De Grazia F, Ferraris L, Cengia G, Greco S, Alvisi C, Scarcelli A, De Luca L, Cereatti F, Testoni PA, Mingotto R, Aragona G, Manes G, Beretta P, Amvrosiadis G, Cennamo V, Lella F, Missale G, Lagoussis P, Triossi O, Giovanardi M, De Roberto G, Cantu P, Buscarini E, Anderloni A, Carrara S, Fugazza A, Galtieri PA, Pellegatta G, Antonelli G, Rosch T, Sharma P (2020) Endoscopy units and the COVID-19 Outbreak: a Multi-Center Experience from Italy. Gastroenterology;]. The endoscopy-related rate of SARS-CoV-2 infection of staff is low, but supply of protective equipment is crucial for this. Endoscopic procedures in COVID-19 patients were not directly related to SARS-CoV-2 infection, but to other underlying diseases or typical complications of long-term ICU treatment. [ABSTRACT FROM AUTHOR]

Published
2021
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173. [Comparison of limited weight values and the sensitivity of analytical methods used for the detection of toxic atmospheric agents in working places].

Author

La Porta V, Maino A, Pellegatta G, Soma R, and Trinci G

Subjects
Aniline Compounds analysis, Dust analysis, Filtration, Humans, Nitroglycerin analysis, Phenols analysis, Air Pollutants analysis, Air Pollutants, Occupational analysis, Environmental Exposure, Maximum Allowable Concentration
Abstract

This research has been carried out in order to estimate minimum sampling periods for the substances detailed in the VLP table given by the Italian Occupational Medicine Service and the Industrial Hygiene Group. These data take the following points into consideration: 1) sensitivity of the analytical method; 2) value and condition of sample at fulfilment of sampling periods; 3) sampling speed; 4) VLP, with special reference to ceiling value for very short exposure. As to dust the minimum period required is about 1 minute for numeric sampling, and 35 minutes for gravimetric sampling. 85% from the above-mentioned substances can be sampled at minimum periods which range from 1 to 5 minutes.

Published
1977

174. Artificial intelligence and colonoscopy experience: Lessons from two randomised trials

Abstract

Background and aims Artificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1). Methods In this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40-80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting. Results In 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis. Conclusions In less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experien

Published
2022

175. Artificial intelligence and colonoscopy experience: Lessons from two randomised trials

Abstract

Background and aims Artificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1). Methods In this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40-80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting. Results In 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis. Conclusions In less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experien

Published
2022

176. Endoscopic ultrasound-guided ablation of solid pancreatic lesions: A systematic review of early outcomes with pooled analysis

Abstract

Contains fulltext : 252157.pdf (Publisher’s version ) (Open Access), BACKGROUND: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is emerging as a complementary therapeutic approach for pancreatic solid masses. However, results of published data are difficult to interpret because of a retrospective design and small sample size. AIM: To systematically review data on EUS-RFA for solid lesions and to pool the results of the different experiences in order to provide more consistent evidence in terms of safety and efficacy. METHODS: A comprehensive systematic literature search on the main databases was performed to identify articles in which patients with pancreatic solid lesions underwent EUS-RFA. The primary outcomes were procedure-related adverse events (AEs) and mortality. Secondary outcomes were the technical success rate and the effects on primary tumor growth. Statistical analyses were performed using Stata version 14.0. RESULTS: In total, 14 studies were included, with 120 patients undergoing 153 ablations of 129 solid pancreatic lesions. The STARmed technology was used in seven studies, the Habib system in six studies, and the HybridTherm probe in one study. The pooled technical success rate was 99.0% (I (2): 25.82%). The pooled overall AE rate was 8.0% (I (2): 11.46%). Excluding mild AEs, the pooled rates of serious AEs was 1.0% (I (2): 0%). No mortality related to the procedure was reported. CONCLUSION: The present pooled analysis confirms the safety and feasibility of EUS-RFA.

Published
2022

177. Endoscopic ultrasound-guided ablation of solid pancreatic lesions: A systematic review of early outcomes with pooled analysis

Abstract

Contains fulltext : 252157.pdf (Publisher’s version ) (Open Access), BACKGROUND: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is emerging as a complementary therapeutic approach for pancreatic solid masses. However, results of published data are difficult to interpret because of a retrospective design and small sample size. AIM: To systematically review data on EUS-RFA for solid lesions and to pool the results of the different experiences in order to provide more consistent evidence in terms of safety and efficacy. METHODS: A comprehensive systematic literature search on the main databases was performed to identify articles in which patients with pancreatic solid lesions underwent EUS-RFA. The primary outcomes were procedure-related adverse events (AEs) and mortality. Secondary outcomes were the technical success rate and the effects on primary tumor growth. Statistical analyses were performed using Stata version 14.0. RESULTS: In total, 14 studies were included, with 120 patients undergoing 153 ablations of 129 solid pancreatic lesions. The STARmed technology was used in seven studies, the Habib system in six studies, and the HybridTherm probe in one study. The pooled technical success rate was 99.0% (I (2): 25.82%). The pooled overall AE rate was 8.0% (I (2): 11.46%). Excluding mild AEs, the pooled rates of serious AEs was 1.0% (I (2): 0%). No mortality related to the procedure was reported. CONCLUSION: The present pooled analysis confirms the safety and feasibility of EUS-RFA.

Published
2022

178. Novel 1-L polyethylene glycol + ascorbate versus high-volume polyethylene glycol regimen for colonoscopy cleansing: a multicenter, randomized, phase IV study

Abstract

Background and Aims: Adequate bowel cleansing is critical to ensure quality and safety of a colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) regimen was previously validated against low-volume regimens but was never compared with high-volume regimens. Methods: In a phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen (4L-PEG) in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by local endoscopists and centralized reading, both blinded to the randomization arm. The primary endpoint was noninferiority of 1L-PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L-PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate, tolerability, and safety. Results: Three hundred eighty-eight patients (median age, 59.8 years) were randomized between January 2019 and October 2019: 195 to 1L-PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L-PEG+ASC was demonstrated for cleansing in both the entire colon (BBPS ≥ 6: 97.9% vs 93%; relative risk [RR], 1.03; 95% confidence interval [CI], 1.001-1.04; P superiority = .027) and in the right-sided colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI, .99-1.02; P noninferiority = .013). Compliance was higher with 1L-PEG+ASC than with 4L-PEG (178/192 [92.7%] vs 154/190 patients [81.1%]; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side effects: 20.8% vs 25.8%; P = .253). No difference in adenoma detection rate (38.8% vs 43.0%) was found. Conclusions: One-liter PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing and provided a higher patient compliance. No differences in tolerability and safety were detected. (Clinical trial registration number: NCT03742232.)

Published
2021

179. Novel 1-L polyethylene glycol + ascorbate versus high-volume polyethylene glycol regimen for colonoscopy cleansing: a multicenter, randomized, phase IV study

Abstract

Background and Aims: Adequate bowel cleansing is critical to ensure quality and safety of a colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) regimen was previously validated against low-volume regimens but was never compared with high-volume regimens. Methods: In a phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen (4L-PEG) in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by local endoscopists and centralized reading, both blinded to the randomization arm. The primary endpoint was noninferiority of 1L-PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L-PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate, tolerability, and safety. Results: Three hundred eighty-eight patients (median age, 59.8 years) were randomized between January 2019 and October 2019: 195 to 1L-PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L-PEG+ASC was demonstrated for cleansing in both the entire colon (BBPS ≥ 6: 97.9% vs 93%; relative risk [RR], 1.03; 95% confidence interval [CI], 1.001-1.04; P superiority = .027) and in the right-sided colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI, .99-1.02; P noninferiority = .013). Compliance was higher with 1L-PEG+ASC than with 4L-PEG (178/192 [92.7%] vs 154/190 patients [81.1%]; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side effects: 20.8% vs 25.8%; P = .253). No difference in adenoma detection rate (38.8% vs 43.0%) was found. Conclusions: One-liter PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing and provided a higher patient compliance. No differences in tolerability and safety were detected. (Clinical trial registration number: NCT03742232.)

Published
2021

180. Pattern of macrovascular invasion in hepatocellular carcinoma

Abstract

Background and aims: In patients with hepatocellular carcinoma (HCC), macrovascular invasion (MaVI) limits treatment options and decreases survival. Detailed data on the relationship between MaVI extension and patients' characteristics, and its impact on patients' outcome are limited. We evaluated the prevalence and extension of MaVI in a large cohort of consecutive HCC patients, analysing its association with liver disease and tumour characteristics, as well as with treatments performed and patients' survival. Methods: We analysed data of 4774 patients diagnosed with HCC recorded in the Italian Liver Cancer (ITA.LI.CA) database (2008-2018). Recursive partition analysis (RPA) was performed to evaluate interactions between MaVI, clinical variables and treatment, exploring the inter-relationship determining overall survival. Results: MaVI prevalence was 11.1%, and median survival of these patients was 6.0 months (95% CI, 5.1-7.1). MaVI was associated with younger age at diagnosis, presence of symptoms, worse Performance Status (PS) and liver function, high alphafetoprotein levels and large HCCs. MaVI extension was associated with worse PS, ascites and greater impairment in liver function. RPA identified patients' categories with different treatment indications and survival, ranging from 2.4 months in those with PS > 1 and ascites, regardless of MaVI extension (receiving best supportive care in 90.3% of cases), to 14.1 months in patients with PS 0-1, no ascites and Vp1-Vp2 MaVI (treated with surgery in 19.1% of cases). Conclusions: MaVI presence and extension, together with PS and ascites, significantly affect patients' survival and treatment selection. The decision tree based on these parameters may help assess patients' prognosis and inform therapeutic decisions.

Published
2021

181. The changing scenario of hepatocellular carcinoma in Italy: an update

Abstract

Background and aims: Epidemiology of hepatocellular carcinoma (HCC) is changing in most areas of the world. This study aimed at updating the changing scenario of aetiology, clinical presentation, management and prognosis of HCC in Italy during the last 15 years. Methods: Retrospective analysis of the Italian Liver Cancer (ITA.LI.CA) database included 6034 HCC patients managed in 23 centres from 2004 to 2018. Patients were divided into three groups according to the date of cancer diagnosis (2004-2008, 2009-2013 and 2014-2018). Results: The main results were: (i) a progressive patient ageing; (ii) a progressive increase of non-viral cases and, particularly, of ‘metabolic’ and ‘metabolic + alcohol’ HCCs; (iii) a slightly decline of cases diagnosed under surveillance, but with an incremental use of the semiannual schedule; (iv) a favourable cancer stage migration; (v) an increased use of radiofrequency ablation to the detriment of percutaneous ethanol injection; (vi) improved outcomes of ablative and transarterial treatments; (vii) an improved overall survival (adjusted for the lead time in surveyed patients) in the last calendar period, particularly in viral patients; (viii) a large gap between the number of potential candidates (according to oncologic criteria and age) to liver transplant and that of transplanted patients. Conclusions: During the last 15 years several aspects of HCC scenario have changed, as well as its management. The improvement in patient survival observed in the last period was likely because of a larger use of thermal ablation with respect to the less effective alcohol injection and to an improved management of intermediate stage patients.

Published
2021

182. Endoscopy Units and the Coronavirus Disease 2019 Outbreak: A Multicenter Experience From Italy

Abstract

Up to 20% of health care personnel (HCP) were found to be infected with coronavirus disease (COVID-19)1 in the outbreak in northern Italy.2 Recommendations on patient and HCP protection have been made, such as postponing procedures, triage, use of personal protective equipment (PPE), and creation of differentiated in-hospital pathways.3,4 However, several barriers against the adoption of these strategies exist, including cultural factors and shortages of medical resources; therefore, there are few reports of real-world experiences and outcomes with their adoption.5 The aim of this survey was to investigate the burden of COVID-19 on endoscopic activity in a high-risk area of COVID-19 outbreak, approaches to evaluating patients, adoption and compliance of HCP with protective measures, and initial possible viral transmission outcomes from endoscopy units within a large, community-based setting (both between patients and HCP and between HCP).

Published
2020

183. Future challenges in gastroenterology and hepatology, between innovations and unmet needs: A SIGE Young Editorial Board's perspective

Author

Antonietta Gerarda Gravina, Leonardo Frazzoni, Giuseppe Losurdo, Alessia Visintin, Luca Maroni, Loris Riccardo Lopetuso, Anna Sessa, Alberto Ferrarese, Gianluca Ianiro, Enrico Maria Gabrieletto, Gaia Pellegatta, Serena Porcari, Losurdo, G., Gravina, A. G., Maroni, L., Gabrieletto, E. M., Ianiro, G., Ferrarese, A., Visintin, A., Frazzoni, L., Pellegatta, G., Sessa, A., Lopetuso, L., and Porcari, S.

Subjects
Transplantation, medicine.medical_specialty, Hepatology, business.industry, Perspective (graphical), Gastroenterology, Endoscopy, Editorial board, Unmet needs, Endoscopy, Gastrointestinal, Digestive endoscopy, Italy, Internal medicine, medicine, Humans, Challenge, Innovation, business, Societies, Medical, Forecasting
Abstract

Gastroenterology, Digestive Endoscopy and Hepatology have faced significant improvements in terms of diagnosis and therapy in the last decades. However, many fields still remain poorly explored, and many questions unanswered. Moreover, basic-science, as well as translational and clinical discoveries, together with technology advancement will determine further steps toward a better, refined care for many gastroenterological disorders in the future. Therefore, the Young Investigators of the Italian Society of Gastroenterology (SIGE) joined together, offering a perspective on major future innovations in some hot clinical topics in Gastroenterology, Endoscopy, and Hepatology, as well as the current pitfalls and the grey zones.

Published
2022

184. Metabolic disorders across hepatocellular carcinoma in Italy

Abstract

Background: Metabolic disorders are well-known risk factors for HCC. Conversely, their impact on the natural history of HCC is not established. This study aimed at evaluating the impact of metabolic disorders on clinical features, treatment and survival of HCC patients regardless of its aetiology. Methods: We analysed the ITA.LI.CA database regarding 839 HCC patients prospectively collected. The following metabolic features were analysed: BMI, diabetes, arterial hypertension, hypercholesterolaemia and hypertriglyceridaemia. According to these features, patients were divided into 3 groups: 0-1, 2 and 3-5 metabolic features. Results: As compared with patients with 0-1 metabolic features, patients with 3-5 features showed lower percentage of HCC diagnosis on surveillance (P =.021), larger tumours (P =.038), better liver function (higher percentage of Child-Pugh class A [P =.007] and MELD < 10 [P =.003]), higher percentage of metastasis (P =.024) and lower percentage of portal vein thrombosis (P =.010). The BCLC stage and treatment options were similar among the 3 groups, with the exception of a less frequent access to loco-regional therapies for BCLC stage B patients with 3-5 features (P =.012). Overall survival and survival according to BCLC stage and/or treatment did not significantly differ among the 3 groups. Only using a probabilistic sensitivity analysis, diabetic patients showed a lower survival (P =.046). MELD score, HCC morphology, nodule size, BCLC stage, portal vein thrombosis and metastasis were independent predictors of lead-time adjusted survival. Conclusions: Our “real world” study suggests that metabolic disorders shape the clinical presentation of HCC but do not seem to play a major role in setting patient survival.

Published
2018

185. Impact of the COVID-19 pandemic on an interdisciplinary endoscopy unit in a German 'hotspot' area: a single center experience

Author

Naushad Bijoy Atique, Julia M Grottenthaler, Christoph R. Werner, Lars Zender, Ulrike Schempf, Stefano Fusco, Nisar P. Malek, Michael Böckeler, Dietmar Stüker, Christian Thiel, Alfred Königsrainer, and Dörte Wichmann

Subjects
Pediatrics, medicine.medical_specialty, Medical staff, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 030204 cardiovascular system & hematology, Single Center, Article, 03 medical and health sciences, 0302 clinical medicine, Emergency bleeding situation, Pandemic, Humans, Medicine, Pandemics, medicine.diagnostic_test, SARS-CoV-2, business.industry, Critically ill, Gastroenterology, COVID-19, Endoscopy, Cohort, 030211 gastroenterology & hepatology, Surgery, business, Interdisciplinary endoscopy, Prevention of infection
Abstract

Background and study aims Since December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative pathogen of coronavirus disease 2019 (COVID-19), has posed a pandemic threat to global health and has challenged health care system in all affected countries. Patients and methods This is a combined study including a descriptive part about the changes in the daily work routine of an Interdisciplinary Endoscopic Unit (IEU) and a prospective analysis of patients tested positive for SARS-CoV-2 who required endoscopic interventions. Conclusively, we present the finding of a point-prevalence analysis in the staff of the IEU. Results We present effects of the COVID-19-related restructuring of processes in our interdisciplinary endoscopy unit (IEU) with respect to cancelation of examinations, relocation of staff to other departments, impact of SARS-CoV-2 on medical staff of the IEU, and supply of protective clothing. Additionally, we analyzed the cohort of COVID-19 patients: Sixteen endoscopic interventions were done in ten patients. In all patients with confirmed infection with SARS-CoV-2, emergency endoscopies were required for relevant bleeding situations. Re-endoscopies were required only in critically ill COVID-19 patients. Conclusions The restructuring of processes in the IEU was feasible in short time, effective, and can also be applied broadly at least in developed countries [Garbe et al. in Gastroenterology 159:778–780, 2020; Repici A, Pace F, Gabbiadini R, Colombo M, Hassan C, Dinelli M, Group IG-CW, Maselli R, Spadaccini M, Mutignani M, Gabbrielli A, Signorelli C, Spada C, Leoni P, Fabbri C, Segato S, Gaffuri N, Mangiavillano B, Radaelli F, Salerno R, Bargiggia S, Maroni L, Benedetti A, Occhipinti P, De Grazia F, Ferraris L, Cengia G, Greco S, Alvisi C, Scarcelli A, De Luca L, Cereatti F, Testoni PA, Mingotto R, Aragona G, Manes G, Beretta P, Amvrosiadis G, Cennamo V, Lella F, Missale G, Lagoussis P, Triossi O, Giovanardi M, De Roberto G, Cantu P, Buscarini E, Anderloni A, Carrara S, Fugazza A, Galtieri PA, Pellegatta G, Antonelli G, Rosch T, Sharma P (2020) Endoscopy units and the COVID-19 Outbreak: a Multi-Center Experience from Italy. Gastroenterology;]. The endoscopy-related rate of SARS-CoV-2 infection of staff is low, but supply of protective equipment is crucial for this. Endoscopic procedures in COVID-19 patients were not directly related to SARS-CoV-2 infection, but to other underlying diseases or typical complications of long-term ICU treatment.

Published
2020

186. Surveillance for hepatocellular carcinoma with a 3-months interval in 'extremely high-risk' patients does not further improve survival

Author

Filippo Pelizzaro, Giulia Peserico, Marco D'Elia, Nora Cazzagon, Francesco Paolo Russo, Alessandro Vitale, Edoardo G. Giannini, Manuela Piccinnu, Gian Ludovico Rapaccini, Maria Di Marco, Eugenio Caturelli, Marco Zoli, Rodolfo Sacco, Giuseppe Cabibbo, Fabio Marra, Andrea Mega, Filomena Morisco, Antonio Gasbarrini, Gianluca Svegliati-Baroni, Francesco Giuseppe Foschi, Andrea Olivani, Alberto Masotto, Gerardo Nardone, Giovanni Raimondo, Francesco Azzaroli, Gianpaolo Vidili, Filippo Oliveri, Franco Trevisani, Fabio Farinati, Maurizio Biselli, Paolo Caraceni, Francesca Garuti, Annagiulia Gramenzi, Andrea Neri, Valentina Santi, Fabio Piscaglia, Francesco Tovoli, Alessandro Granito, Luca Muratori, Francesca Benevento, Elton Dajti, Giovanni Marasco, Federico Ravaioli, Alberta Cappelli, Rita Golfieri, Cristina Mosconi, Matteo Renzulli, Angela Imondi, Anna Sartori, Barbara Penzo, Elisa Pinto, Ester Marina Cela, Antonio Facciorusso, Valentina Cacciato, Edoardo Casagrande, Alessandro Moscatelli, Gaia Pellegatta, Nicoletta De Matthaeis, Gloria Allegrini, Valentina Lauria, Giorgia Ghittoni, Giorgio Pelecca, Fabrizio Chegai, Fabio Coratella, Mariano Ortenzi, Gabriele Missale, Alessandro Inno, Fabiana Marchetti, Anita Busacca, Calogero Cammà, Vincenzo Di Martino, Giacomo Emanuele Maria Rizzo, Maria Stella Franzè, Carlo Saitta, Assunta Sauchella, Vittoria Bevilacqua, Alberto Borghi, Andrea Casadei Gardini, Fabio Conti, Anna Chiara Dall'aglio, Giorgio Ercolani, Federica Mirici, Claudia Campani, Chiara Di Bonaventura, Stefano Gitto, Pietro Coccoli, Antonio Malerba, Maria Guarino, Maurizia Brunetto, Veronica Romagnoli, Pelizzaro, F., Peserico, G., D'Elia, M., Cazzagon, N., Russo, F. P., Vitale, A., Giannini, E. G., Piccinnu, M., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Sacco, R., Cabibbo, G., Marra, F., Mega, A., Morisco, F., Gasbarrini, A., Svegliati-Baroni, G., Foschi, F. G., Olivani, A., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Trevisani, F., Farinati, F., Biselli, M., Caraceni, P., Garuti, F., Gramenzi, A., Neri, A., Santi, V., Piscaglia, F., Tovoli, F., Granito, A., Muratori, L., Benevento, F., Dajti, E., Marasco, G., Ravaioli, F., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Imondi, A., Sartori, A., Penzo, B., Pinto, E., Cela, E. M., Facciorusso, A., Cacciato, V., Casagrande, E., Moscatelli, A., Pellegatta, G., De Matthaeis, N., Allegrini, G., Lauria, V., Ghittoni, G., Pelecca, G., Chegai, F., Coratella, F., Ortenzi, M., Missale, G., Inno, A., Marchetti, F., Busacca, A., Camma, C., Di Martino, V., Rizzo, G. E. M., Franze, M. S., Saitta, C., Sauchella, A., Bevilacqua, V., Borghi, A., Casadei Gardini, A., Conti, F., Dall'Aglio, A. C., Ercolani, G., Mirici, F., Campani, C., Di Bonaventura, C., Gitto, S., Coccoli, P., Malerba, A., Guarino, M., Brunetto, M., Romagnoli, V., Pelizzaro, Filippo, Peserico, Giulia, D'Elia, Marco, Cazzagon, Nora, Russo, Francesco Paolo, Vitale, Alessandro, Giannini, Edoardo G., Piccinnu, Manuela, Rapaccini, Gian Ludovico, Di Marco, Maria, Caturelli, Eugenio, Zoli, Marco, Sacco, Rodolfo, Cabibbo, Giuseppe, Marra, Fabio, Mega, Andrea, Morisco, Filomena, Gasbarrini, Antonio, Svegliati-Baroni, Gianluca, Foschi, Francesco Giuseppe, Olivani, Andrea, Masotto, Alberto, Nardone, Gerardo, Raimondo, Giovanni, Azzaroli, Francesco, Vidili, Gianpaolo, Oliveri, Filippo, Trevisani, Franco, Farinati, Fabio, Biselli, Maurizio, Caraceni, Paolo, Garuti, Francesca, Gramenzi, Annagiulia, Neri, Andrea, Santi, Valentina, Piscaglia, Fabio, Tovoli, Francesco, Granito, Alessandro, Muratori, Luca, Benevento, Francesca, Dajti, Elton, Marasco, Giovanni, Ravaioli, Federico, Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Imondi, Angela, Sartori, Anna, Penzo, Barbara, Pinto, Elisa, Cela, Ester Marina, Facciorusso, Antonio, Cacciato, Valentina, Casagrande, Edoardo, Moscatelli, Alessandro, Pellegatta, Gaia, De Matthaeis, Nicoletta, Allegrini, Gloria, Lauria, Valentina, Ghittoni, Giorgia, Pelecca, Giorgio, Chegai, Fabrizio, Coratella, Fabio, Ortenzi, Mariano, Missale, Gabriele, Inno, Alessandro, Marchetti, Fabiana, Busacca, Anita, Cammà, Calogero, Di Martino, Vincenzo, Rizzo, Giacomo Emanuele Maria, Franzè, Maria Stella, Saitta, Carlo, Sauchella, Assunta, Bevilacqua, Vittoria, Borghi, Alberto, Casadei Gardini, Andrea, Conti, Fabio, Dall'aglio, Anna Chiara, Ercolani, Giorgio, Mirici, Federica, Campani, Claudia, Di Bonaventura, Chiara, Gitto, Stefano, Coccoli, Pietro, Malerba, Antonio, Guarino, Maria, Brunetto, Maurizia, and Romagnoli, Veronica

Subjects
medicine.medical_specialty, Carcinoma, Hepatocellular, Survival, Hepatocellular carcinoma, Cancer stage, Surveillance interval, Internal medicine, medicine, Humans, Propensity Score, Survival analysis, High risk patients, Hepatology, business.industry, Liver Neoplasms, Settore MED/09 - MEDICINA INTERNA, Gastroenterology, Patient survival, medicine.disease, Survival Analysis, Propensity score matching, Survival Analysi, Liver cancer, business, Median survival, Human
Abstract

Background An enhanced surveillance schedule has been proposed for cirrhotics with viral etiology, who are considered at extremely high-risk of hepatocellular carcinoma (HCC). Aims We compared the 3- and 6-months surveillance interval, evaluating cancer stage at diagnosis and patient survival. Methods Data of 777 HBV and HCV cirrhotic patients with HCC diagnosed under a 3-months (n = 109, 3MS group) or a 6-months (n = 668, 6MS group) surveillance were retrieved from the Italian Liver Cancer database. Survival in the 3MS group was considered as observed and adjusted for lead-time bias, and survival analysis was repeated after a propensity score matching. Results The 3-months surveillance interval neither reduced the share of patients diagnosed outside the Milano criteria, nor increased their probability to receive curative treatments. The median survival of 6MS patients (55.0 months [45.9–64.0]) was not significantly different from the observed (47.0 months [35.0–58.9]; p = 0.43) and adjusted (44.9 months [33.4–56.4]; p = 0.30) survival of 3MS patients. A propensity score analysis confirmed the absence of a survival advantage for 3MS patients. Conclusions A tightening of surveillance schedule does not increase the diagnosis of early-stage tumors, the feasibility of curative treatments and the survival. Therefore, we should maintain the 6-months interval in the surveillance of viral cirrhotics.

Published
2022

187. Microbiota Gut–Brain Axis in Ischemic Stroke: A Narrative Review with a Focus about the Relationship with Inflammatory Bowel Disease

Author

Marcello Maida, Emanuele Sinagra, Valentina Guarnotta, Socrate Pallio, Giuseppe Conoscenti, Dario Raimondo, Francesca Rossi, Fabio Pace, Gaia Pellegatta, Rita Alloro, Andrea Anderloni, and Sinagra E, Pellegatta G, Guarnotta V, Maida M, Rossi F, Conoscenti G, Pallio S, Alloro R, Raimondo D, Pace F, Anderloni A.

Subjects
0301 basic medicine, brain, Science, Gut–brain axis, Review, Disease, Gut flora, Bioinformatics, Inflammatory bowel disease, digestive system, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, 0302 clinical medicine, inflammatory bowel disease, microbiota, Medicine, Stroke, Ecology, Evolution, Behavior and Systematics, biology, business.industry, stroke, digestive, oral, and skin physiology, Paleontology, Inflammatory Bowel Diseases, biology.organism_classification, medicine.disease, stomatognathic diseases, 030104 developmental biology, Space and Planetary Science, Ischemic stroke, gut, Narrative review, business, 030217 neurology & neurosurgery
Abstract

The gut microbiota is emerging as an important player in neurodevelopment and aging as well as in brain diseases including stroke, Alzheimer’s disease, and Parkinson’s disease. The complex interplay between gut microbiota and the brain, and vice versa, has recently become not only the focus of neuroscience, but also the starting point for research regarding many diseases such as inflammatory bowel diseases (IBD). The bi-directional interaction between gut microbiota and the brain is not completely understood. The aim of this review is to sum up the evidencesconcerningthe role of the gut–brain microbiota axis in ischemic stroke and to highlight the more recent evidences about the potential role of the gut–brain microbiota axis in the interaction between inflammatory bowel disease and ischemic stroke.

Published
2021

188. Monofocal hepatocellular carcinoma: How much does size matter?

Author

Pelizzaro, Filippo, Penzo, Barbara, Peserico, Giulia, Imondi, Angela, Sartori, Anna, Vitale, Alessandro, Cillo, Umberto, Giannini, Edoardo G., Forgione, Antonella, Ludovico Rapaccini, Gian, Di Marco, Maria, Caturelli, Eugenio, Zoli, Marco, Sacco, Rodolfo, Cabibbo, Giuseppe, Marra, Fabio, Mega, Andrea, Morisco, Filomena, Gasbarrini, Antonio, Svegliati‐Baroni, Gianluca, Giuseppe Foschi, Francesco, Olivani, Andrea, Masotto, Alberto, Nardone, Gerardo, Raimondo, Giovanni, Azzaroli, Francesco, Vidili, Gianpaolo, Oliveri, Filippo, Trevisani, Franco, Farinati, Fabio, Biselli, Maurizio, Caraceni, Paolo, Garuti, Francesca, Gramenzi, Annagiulia, Neri, Andrea, Santi, Valentina, Granito, Alessandro, Muratori, Luca, Piscaglia, Fabio, Sansone, Vito, Tovoli, Francesco, Dajti, Elton, Marasco, Giovanni, Ravaioli, Federico, Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Sammarco, Ambra, Cela, Ester Marina, Facciorusso, Antonio, Cacciato, Valentina, Casagrande, Edoardo, Moscatelli, Alessandro, Pellegatta, Gaia, de Matthaeis, Nicoletta, Allegrini, Gloria, Lauria, Valentina, Ghittoni, Giorgia, Pelecca, Giorgio, Chegai, Fabrizio, Coratella, Fabio, Ortenzi, Mariano, Missale, Gabriele, Inno, Alessandro, Marchetti, Fabiana, Busacca, Anita, Cammà, Calogero, Martino, Vincenzo Di, Emanuele Maria Rizzo, Giacomo, Franzè, Maria Stella, Saitta, Carlo, Sauchella, Assunta, Bevilacqua, Vittoria, Borghi, Alberto, Casadei Gardini, Andrea, Conti, Fabio, Dall'Aglio, Anna Chiara, Ercolani, Giorgio, Mirici, Federica, Campani, Claudia, Bonaventura, Chiara Di, Gitto, Stefano, Coccoli, Pietro, Malerba, Antonio, Guarino, Maria, Brunetto, Maurizia, Romagnoli, Veronica, Pelizzaro, Filippo, Penzo, Barbara, Peserico, Giulia, Imondi, Angela, Sartori, Anna, Vitale, Alessandro, Cillo, Umberto, Giannini, Edoardo G., Forgione, Antonella, Ludovico Rapaccini, Gian, Di Marco, Maria, Caturelli, Eugenio, Zoli, Marco, Sacco, Rodolfo, Cabibbo, Giuseppe, Marra, Fabio, Mega, Andrea, Morisco, Filomena, Gasbarrini, Antonio, Svegliati‐Baroni, Gianluca, Giuseppe Foschi, Francesco, Olivani, Andrea, Masotto, Alberto, Nardone, Gerardo, Raimondo, Giovanni, Azzaroli, Francesco, Vidili, Gianpaolo, Oliveri, Filippo, Trevisani, Franco, Farinati, Fabio, Biselli, Maurizio, Caraceni, Paolo, Garuti, Francesca, Gramenzi, Annagiulia, Neri, Andrea, Santi, Valentina, Granito, Alessandro, Muratori, Luca, Piscaglia, Fabio, Sansone, Vito, Tovoli, Francesco, Dajti, Elton, Marasco, Giovanni, Ravaioli, Federico, Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Sammarco, Ambra, Cela, Ester Marina, Facciorusso, Antonio, Cacciato, Valentina, Casagrande, Edoardo, Moscatelli, Alessandro, Pellegatta, Gaia, de Matthaeis, Nicoletta, Allegrini, Gloria, Lauria, Valentina, Ghittoni, Giorgia, Pelecca, Giorgio, Chegai, Fabrizio, Coratella, Fabio, Ortenzi, Mariano, Missale, Gabriele, Inno, Alessandro, Marchetti, Fabiana, Busacca, Anita, Cammà, Calogero, Martino, Vincenzo Di, Emanuele Maria Rizzo, Giacomo, Franzè, Maria Stella, Saitta, Carlo, Sauchella, Assunta, Bevilacqua, Vittoria, Borghi, Alberto, Casadei Gardini, Andrea, Conti, Fabio, Dall'Aglio, Anna Chiara, Ercolani, Giorgio, Mirici, Federica, Campani, Claudia, Bonaventura, Chiara Di, Gitto, Stefano, Coccoli, Pietro, Malerba, Antonio, Guarino, Maria, Brunetto, Maurizia, Romagnoli, Veronica, Giannini, Edoardo G, Svegliati-Baroni, Gianluca, for the Italica, Group, Pelizzaro F., Penzo B., Peserico G., Imondi A., Sartori A., Vitale A., Cillo U., Giannini E.G., Forgione A., Ludovico Rapaccini G., Di Marco M., Caturelli E., Zoli M., Sacco R., Cabibbo G., Marra F., Mega A., Morisco F., Gasbarrini A., Svegliati-Baroni G., Giuseppe Foschi F., Olivani A., Masotto A., Nardone G., Raimondo G., Azzaroli F., Vidili G., Oliveri F., Trevisani F., Farinati F., Biselli M., Caraceni P., Garuti F., Gramenzi A., Neri A., Santi V., Granito A., Muratori L., Piscaglia F., Sansone V., Tovoli F., Dajti E., Marasco G., Ravaioli F., Cappelli A., Golfieri R., Mosconi C., Renzulli M., Sammarco A., Cela E.M., Facciorusso A., Cacciato V., Casagrande E., Moscatelli A., Pellegatta G., de Matthaeis N., Allegrini G., Lauria V., Ghittoni G., Pelecca G., Chegai F., Coratella F., Ortenzi M., Missale G., Inno A., Marchetti F., Busacca A., Qabibboz G., Camma C., Martino V.D., Emanuele Maria Rizzo G., Franze M.S., Saitta C., Sauchella A., Bevilacqua V., Borghi A., Casadei Gardini A., Conti F., Dall'Aglio A.C., Ercolani G., Mirici F., Campani C., Bonaventura C.D., Gitto S., Coccoli P., Malerba A., Guarino M., Brunetto M., Romagnoli V., Rapaccini, Gian Ludovico, and Foschi, Francesco Giuseppe

Subjects
medicine.medical_specialty, Multivariate analysis, Carcinoma, Hepatocellular, Independent predictor, Gastroenterology, Resection, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Overall survival, Hepatectomy, Humans, Staging system, Neoplasm Staging, Retrospective Studies, Settore MED/12 - Gastroenterologia, Hepatology, treatment, business.industry, Settore MED/09 - MEDICINA INTERNA, Liver Neoplasms, bclc staging system, monofocal hepatocellular carcinoma, medicine.disease, digestive system diseases, Survival benefit, Italy, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, liver resection, prognosis, 030211 gastroenterology & hepatology, business, Liver cancer, prognosi
Abstract

Background & Aims: According to the Barcelona Clinic Liver Cancer (BCLC) staging system, monofocal hepatocellular carcinoma (HCC) is classified as early (BCLC A) irrespective of its size, even though controversies still exist regarding staging and treatment of large tumours. We aimed at evaluating the appropriate staging and treatment for large (>5cm) monofocal (HCC). Methods: From the Italian Liver Cancer database, we selected 924 patients with small early monofocal HCC (2-5cm; SEM-HCC), 163 patients with larger tumours (>5cm; LEM-HCC) and 1048 intermediate stage patients (BCLC B). Results: LEM-HCC patients had a worse overall survival (OS) than SEM-HCC (31.0 vs 49.0months; P&nbsp

Published
2021

189. Advancements in the use of manometry and impedance testing for esophageal functional disorders

Author

Patrizia Zentilin, Elisa Marabotto, Brigida Barberio, Gaia Pellegatta, Edoardo Savarino, Vincenzo Savarino, Marzio Frazzoni, Giorgia Bodini, Nicola de Bortoli, Andrea Ottonello, Matteo Ghisa, Salvatore Tolone, Manuele Furnari, Marco Della Coletta, Savarino, E., Marabotto, E., Bodini, G., Furnari, M., Della Coletta, M., Ghisa, M., Barberio, B., Frazzoni, M., De Bortoli, N., Zentilin, P., Pellegatta, G., Tolone, S., Ottonello, A., and Savarino, V.

Subjects
Impedance testing, esophageal motor disorders, Manometry, Prognosi, Predictive Value of Test, esophageal function, HRM combined with impedance, Esophageal Disease, Esophageal Diseases, Esophagu, Esophageal function, 03 medical and health sciences, 0302 clinical medicine, Esophagus, Predictive Value of Tests, Electric Impedance, Pressure, Medicine, Humans, esophageal motor disorder, Chicago Classification, high-resolution manometry, impedance technology, manometric evaluation, High resolution manometry, Hepatology, business.industry, Gastroenterology, Prognosis, Deglutition, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Gastrointestinal Motility, business, Biomedical engineering, Human
Abstract

Introduction. The utilization of high-resolution manometry (HRM) has enhanced our understanding and assessment of esophageal motor disorders. Moreover, the combination of impedance technology with HRM (HRIM) has further improved our knowledge of esophageal physiology and the clinical evaluation of dysmotility, thanks to the addition of accurate measurement of bolus transit. Areas covered. This paper provides an overview of current knowledge in the use of HRIM for the study of esophageal functional disorders by reporting mainly the results of many publications and several systematic reviews in this field. Expert opinion. HRIM has represented a relevant improvement in the assessment of esophageal motility and has required the development of new metrics, such as the esophageal impedance integral ratio, the bolus flow time, the nadir impedance pressure and the impedance bolus height, which increase the evaluation of esophageal bolus transit. An extension of impedance is represented by functional lumen imaging probe (FLIP), which determines the biophysical properties and the distensibility of the esophagus and permits to detect contractility patterns not seen on HRM alone. We eagerly wait for a new and fruitful iteration of the Chicago Classification, now in version 3.0, which can cover the ongoing clinical experience of HRIM.

Published
2019

190. A meta-analysis of single HCV-untreated arm of studies evaluating outcomes after curative treatments of HCV-related hepatocellular carcinoma

Author

Cabibbo, Giuseppe, Petta, Salvatore, Barbã ra, Marco, Missale, Gabriele, Virdone, Roberto, Caturelli, Eugenio, Piscaglia, Fabio, Morisco, Filomena, Colecchia, Antonio, Farinati, Fabio, Giannini, Edoardo, Trevisani, Franco, Craxã¬, Antonio, Colombo, Massimo, Cammã , Calogero, Bucci, Laura, Zoli, Marco, Garuti, Francesca, Lenzi, Barbara, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Gramenzi, Annagiulia, Granito, Alessandro, Magalotti, Donatella, Serra, Carla, Negrini, Giulia, Napoli, Lucia, Salvatore, Veronica, Benevento, Francesca, Benvegnã¹, Luisa, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Ciccarese, Francesca, Del Poggio, Paolo, Olmi, Stefano, de Matthaeis, Nicoletta, Balsamo, Mariella Di Marco Claudia, Vavassori, Elena, Roselli, Paola, Dell’Isola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Attardo, Simona, Rossi, Margherita, Costantino, Andrea, Affronti, Andrea, Affronti, Marco, Mascari, Marta, Felder, Martina, Mega, Andrea, Gasbarrini, Antonio, Pompili, Maurizio, Rinninella, Emanuele, Sacco, Rodolfo, Mismas, Valeria, Foschi, Francesco Giuseppe, Dall’Aglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Cappa, Federica Mirici, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Olivani, Andrea, Biasini, Elisabetta, Nardone, Gerardo, Guarino, Maria, Svegliati-Baroni, Gialuca, Ortolani, Alessio, Masotto, Alberto, Marchetti, Fabiana, Valerio, Matteo, Marra, Fabio, Aburas, Sami, Inghilesi, Andrea L, Cappelli, Alberta, Golfieri, Rita, Mosconi, MARIA CRISTINA, Renzulli, Matteo, Coccoli, Piero, Zamparelli, Marco Sanduzzi, Benvegnu', Luisa, Cabibbo, Giuseppe, Petta, Salvatore, Barbàra, Marco, Missale, Gabriele, Virdone, Roberto, Caturelli, Eugenio, Piscaglia, Fabio, Morisco, Filomena, Colecchia, Antonio, Farinati, Fabio, Giannini, Edoardo, Trevisani, Franco, Craxì, Antonio, Colombo, Massimo, Cammà, Calogero, Nardone, GERARDO ANTONIO PIO, Cabibbo, G., Petta, S., Barbara, M., Missale, G., Virdone, R., Caturelli, E., Piscaglia, F., Morisco, F., Colecchia, A., Farinati, F., Giannini, E., Trevisani, F., Craxi, A., Colombo, M., Camma, C., Bucci, L., Zoli, M., Garuti, F., Lenzi, B., Biselli, M., Caraceni, P., Cucchetti, A., Gramenzi, A., Granito, A., Magalotti, D., Serra, C., Negrini, G., Napoli, L., Salvatore, V., Benevento, F., Benvegnu, L., Gazzola, A., Murer, F., Pozzan, C., Vanin, V., Moscatelli, A., Pellegatta, G., Picciotto, A., Savarino, V., Ciccarese, F., Del Poggio, P., Olmi, S., de Matthaeis, N., Balsamo, M. D. M. C., Vavassori, E., Roselli, P., Dell'Isola, S., Ialungo, A. M., Rastrelli, E., Attardo, S., Rossi, M., Costantino, A., Affronti, A., Affronti, M., Mascari, M., Felder, M., Mega, A., Gasbarrini, A., Pompili, M., Rinninella, E., Sacco, R., Mismas, V., Foschi, F. G., Dall'Aglio, A. C., Feletti, V., Lanzi, A., Cappa, F. M., Neri, E., Stefanini, G. F., Tamberi, S., Olivani, A., Biasini, E., Nardone, G., Guarino, M., Svegliati-Baroni, G., Ortolani, A., Masotto, A., Marchetti, F., Valerio, M., Marra, F., Aburas, S., Inghilesi, A. L., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Coccoli, P., Zamparelli, M. S., Barbã ra, Marco, Craxã¬, Antonio, Cammã , Calogero, Bucci, Laura, Zoli, Marco, Garuti, Francesca, Lenzi, Barbara, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Gramenzi, Annagiulia, Granito, Alessandro, Magalotti, Donatella, Serra, Carla, Negrini, Giulia, Napoli, Lucia, Salvatore, Veronica, Benevento, Francesca, Benvegnã¹, Luisa, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Ciccarese, Francesca, Del Poggio, Paolo, Olmi, Stefano, de Matthaeis, Nicoletta, Balsamo, Mariella Di Marco Claudia, Vavassori, Elena, Roselli, Paola, Dellâ isola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Attardo, Simona, Rossi, Margherita, Costantino, Andrea, Affronti, Andrea, Affronti, Marco, Mascari, Marta, Felder, Martina, Mega, Andrea, Gasbarrini, Antonio, Pompili, Maurizio, Rinninella, Emanuele, Sacco, Rodolfo, Mismas, Valeria, Foschi, Francesco Giuseppe, Dallâ aglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Federica Mirici, Cappa, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Olivani, Andrea, Biasini, Elisabetta, Nardone, Gerardo, Guarino, Maria, Svegliati-Baroni, Gialuca, Ortolani, Alessio, Masotto, Alberto, Marchetti, Fabiana, Valerio, Matteo, Marra, Fabio, Aburas, Sami, Inghilesi, Andrea L, Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Coccoli, Piero, Zamparelli, Marco Sanduzzi, Camma', C., Benvegnã¹, L., Balsamo, M., Dell’Isola, S., Ialungo, A., Foschi, F., Dall’Aglio, A., Cappa, F., Stefanini, G., Inghilesi, A., and Zamparelli, M.

Subjects
Oncology, medicine.medical_specialty, Carcinoma, Hepatocellular, recurrence, Hepatitis C virus, medicine.medical_treatment, medicine.disease_cause, survival, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Adjuvant therapy, hepatocellular carcinoma, prognosis, recurrences, Humans, Survival analysis, Hepatology, business.industry, Liver Neoplasms, medicine.disease, Hepatitis C, 030220 oncology & carcinogenesis, Meta-analysis, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Neoplasm Recurrence, Local, business, Adjuvant, prognosi
Abstract

Background & Aims: Determining risk for recurrence or survival after curative resection or ablation in patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) is important for stratifying patients according to expected outcomes in future studies of adjuvant therapy in the era of direct-acting antivirals (DAAs). The aims of this meta-analysis were to estimate the recurrence and survival probabilities of HCV-related early HCC following complete response after potentially curative treatment and to identify predictors of recurrence and survival. Methods: Studies reporting time-dependent outcomes (HCC recurrence or death) after potentially curative treatment of HCV-related early HCC were identified in MEDLINE through May 2016. Data on patient populations and outcomes were extracted from each study by three independent observers and combined using a distribution-free summary survival curve. Primary outcomes were actuarial probabilities of recurrence and survival. Results: Eleven studies met the inclusion criteria. Pooled estimates of actuarial recurrence rates were 7.4% at 6months and 47.0% at 2years. Pooled estimates of actuarial survival rates were 79.8% at 3years and 58.6% at 5years. Heterogeneity among studies was highly significant for all outcomes. By univariate meta-regression analyses, lower serum albumin, randomized controlled trial study design and follow-up were independently associated with higher recurrence risk, whereas tumour size and alpha-foetoprotein levels were associated with higher mortality. Conclusions: This meta-analysis showed that recurrence risk and survival are extremely variable in patients with successfully treated HCV-related HCC, providing a useful benchmark for indirect comparisons of the benefits of DAAs and for a correct design of randomized controlled trials in the adjuvant setting.

Published
2017

191. Hepatocellular carcinoma recurrence in patients with curative resection or ablation: impact of HCV eradication does not depend on the use of interferon

Author

Petta, S., Cabibbo, G., Barbara, M., Attardo, S., Bucci, L., Farinati, F., Giannini, E. G., Tovoli, F., Ciccarese, F., Rapaccini, Gian Ludovico, Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Virdone, R., Marra, F., Felder, M., Morisco, F., Benvegnù, L., Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Olivani, A., Masotto, A., Nardone, G., Colecchia, A., Persico, M., Boccaccio, V., Craxì, A., Bruno, S., Trevisani, F., Cammà, C, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Domenicali, Marco, Piscaglia, Fabio, Gramenzi, Annagiulia, Granito, Alessandro, Magalotti, Donatella, Serra, Carla, Negrini, Giulia, Napoli, L., Napoli, Lucia, Salvatore, Veronica, Benevento, Francesca, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Delpoggio, Paolo, Olmi, Stefano, De Matthaeis, Nicoletta, Balsamo, Claudia, Vavassori, Elena, Roselli, Paola, Dell’Isola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Rini, Francesca, Costantino, Andrea, Affronti, Andrea, Affronti, Marco, Mascari, Marta, Mega, Andrea, Pompili, Maurizio, Rinninella, Emanuele, Mismas, Valeria, Dall’Aglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Cappa, Federica Mirici, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Biasini, Elisabetta, Missale, Gabriele, Guarino, Maria, Ortolani, Alessio, Chiaramonte, Maria, Marchetti, Fabiana, Valerio, Matteo, Aburas, Sami, Inghilesi, Andrea L., Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Coccoli, Piero, Zamparelli, Marco Sanduzzi, Petta, Salvatore, Cabibbo, Giuseppe, Barbara, Marco, Attardo, Simona, Bucci, Laura, Farinati, Fabio, Giannini, Edoardo G., Tovoli, Francesco, Ciccarese, Francesca, Rapaccini, Gian Lodovico, Dimarco, Maria, Caturelli, Eugenio, Zoli, Marco, Borzio, Franco, Sacco, Rodolfo, Virdone, Roberto, Marra, Fabio, Felder, Martina, Morisco, Filomena, Benvegnù, Luisa, Svegliati-Baroni, Gianluca, Foschi, Francesco Giuseppe, Olivani, Andrea, Masotto, Alberto, Nardone, Gerardo, Colecchia, Antonio, Persico, Marcello, Boccaccio, Vincenzo, Craxì, Antonio, Bruno, Savino, Trevisani, Franco, Cammà, Calogero, Petta, S, Cabibbo, G, Barbara, M, Attardo, S, Bucci, L, Farinati, F, Giannini, E. G, Tovoli, F, Ciccarese, F, Rapaccini, G. L, Di Marco, M, Caturelli, E, Zoli, M, Borzio, F, Sacco, R, Virdone, R, Marra, F, Felder, M, Morisco, Filomena, Benvegnù, L, Gasbarrini, A, Svegliati Baroni, G, Foschi, F. G, Olivani, A, Masotto, A, Nardone, GERARDO ANTONIO PIO, Colecchia, A, Persico, M, Boccaccio, V, Craxì, A, Bruno, S, Trevisani, F, Cammà, C., DIPARTIMENTO DI MEDICINA SPECIALISTICA, DIAGNOSTICA E SPERIMENTALE, DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, Facolta' di MEDICINA e CHIRURGIA, Da definire, AREA MIN. 06 - Scienze mediche, Petta, S., Cabibbo, G., Barbara, M., Attardo, S., Bucci, L., Farinati, F., Giannini, E., Tovoli, F., Ciccarese, F., Rapaccini, G., Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Virdone, R., Marra, F., Felder, M., Morisco, F., Benvegnã¹, L., Gasbarrini, A., Svegliati-Baroni, G., Foschi, F., Olivani, A., Masotto, A., Nardone, G., Colecchia, A., Persico, M., Boccaccio, V., Craxi, A., Bruno, S., Trevisani, F., Camma', C., Biselli, M., Caraceni, P., Cucchetti, A., Domenicali, M., Piscaglia, F., Gramenzi, A., Granito, A., Magalotti, D., Serra, C., Negrini, G., Napoli, L., Salvatore, V., Benevento, F., Gazzola, A., Murer, F., Pozzan, C., Vanin, V., Moscatelli, A., Pellegatta, G., Picciotto, A., Savarino, V., Delpoggio, P., Olmi, S., Dematthaeis, N., Balsamo, C., Vavassori, E., Roselli, P., Dell’Isola, S., Ialungo, A., Rastrelli, E., Rini, F., Costantino, A., Affronti, A., Affronti, M., Mascari, M., Mega, A., Pompili, M., Rinninella, E., Mismas, V., Dall’Aglio, A., Feletti, V., Lanzi, A., Cappa, F., Neri, E., Stefanini, G., Tamberi, S., Biasini, E., Missale, G., Guarino, M., Ortolani, A., Chiaramonte, M., Marchetti, F., Valerio, M., Aburas, S., Inghilesi, A., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Coccoli, P., Zamparelli, M., Giannini, E.G., Rapaccini, G.L., Benvegnù, L., Foschi, F.G., Craxì, A., Cammà, C, the Italian Liver Cancer (ITALICA) Group [, Maurizio Biselli, Paolo Caraceni, Alessandro Cucchetti, Marco Domenicali, Fabio Piscaglia, Annagiulia Gramenzi, Alessandro Granito, Donatella Magalotti, Carla Serra, Giulia Negrini, Lucia Napoli, Veronica Salvatore, Francesca Benevento, ], Giannini, E. G., Rapaccini, G. L., Benvegnu, L., Foschi, F. G., Camma, C., Dell'Isola, S., Ialungo, A. M., Dall'Aglio, A. C., Cappa, F. M., Stefanini, G. F., Inghilesi, A. L., and Zamparelli, M. S.

Subjects
Liver Cirrhosis, Male, Cirrhosis, Databases, Factual, Gastroenterology, HCV-infected cirrhotic patients, hepatocellular carcinoma, HCC, sustained viral eradication, SVR, interferon, 0302 clinical medicine, Retrospective Studie, Pharmacology (medical), Prospective Studies, Prospective cohort study, Aged, 80 and over, Liver Neoplasms, virus diseases, Hepatitis C, Middle Aged, Liver Neoplasm, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Catheter Ablation, Interferon, 030211 gastroenterology & hepatology, Female, Liver cancer, Human, Adult, medicine.medical_specialty, Carcinoma, Hepatocellular, Liver Cirrhosi, Antiviral Agents, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Carcinoma, Early Hepatocellular Carcinoma, Humans, Aged, Retrospective Studies, Antiviral Agent, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, Retrospective cohort study, medicine.disease, digestive system diseases, Surgery, Prospective Studie, Interferons, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

none 48 no Background: In HCV-infected cirrhotic patients with successfully treated early hepatocellular carcinoma (HCC), the time to HCC recurrence and the effects of sustained viral eradication (SVR) by interferon (IFN)-based or IFN-free regimens on HCC recurrence remain unclear. Aim: To perform an indirect comparison of time to recurrence (TTR) in patients with successfully treated early HCC and active HCV infection with those of patients with SVR by IFN-based and by IFN-free regimens. Methods: We evaluated 443 patients with HCV-related cirrhosis and Barcelona Clinic Liver Cancer Stage A/0 HCC who had a complete radiological response after curative resection or ablation. Active HCV infection was present in 328, selected from the Italian Liver Cancer group cohort; 58 patients had SVR achieved by IFN-free regimens after HCC cure, and 57 patients had SVR achieved by IFN-based regimens after HCC cure. Individual data of patients in the last two groups were extracted from available publications. Results: TTR by Kaplan–Meier curve was significantly lower in patients with active HCV infection compared with those with SVR both by IFN-free (P = 0.02) and by IFN-based (P < 0.001) treatments. TTR was similar in patients with SVR by IFN-free or by IFN-based (P = 0.49) strategies. Conclusion: In HCV-infected, successfully treated patients with early HCC, SVR obtained by IFN-based or IFN-free regimens significantly reduce tumour recurrence without differences related to the anti-viral strategy used. Petta, S.; Cabibbo, G.; Barbara, M.; Attardo, S.; Bucci, L.; Farinati, F.; Giannini, E.G.; Tovoli, F.; Ciccarese, F.; Rapaccini, G.L.; Di Marco, M.; Caturelli, E.; Zoli, M.; Borzio, F.; Sacco, R.; Virdone, R.; Marra, F.; Felder, M.; Morisco, F.; Benvegnù, L.; Gasbarrini, A.; Svegliati-Baroni, G.; Foschi, F.G.; Olivani, A.; Masotto, A.; Nardone, G.; Colecchia, A.; Persico, M.; Boccaccio, V.; Craxì, A.; Bruno, S.; Trevisani, F.; Cammà, C; the Italian Liver Cancer (ITALICA) Group [ ; Maurizio Biselli; Paolo Caraceni; Alessandro Cucchetti; Marco Domenicali; Fabio Piscaglia; Annagiulia Gramenzi; Alessandro Granito; Donatella Magalotti; Carla Serra; Giulia Negrini; Lucia Napoli; Veronica Salvatore; Francesca Benevento;] Petta, S.; Cabibbo, G.; Barbara, M.; Attardo, S.; Bucci, L.; Farinati, F.; Giannini, E.G.; Tovoli, F.; Ciccarese, F.; Rapaccini, G.L.; Di Marco, M.; Caturelli, E.; Zoli, M.; Borzio, F.; Sacco, R.; Virdone, R.; Marra, F.; Felder, M.; Morisco, F.; Benvegnù, L.; Gasbarrini, A.; Svegliati-Baroni, G.; Foschi, F.G.; Olivani, A.; Masotto, A.; Nardone, G.; Colecchia, A.; Persico, M.; Boccaccio, V.; Craxì, A.; Bruno, S.; Trevisani, F.; Cammà, C; the Italian Liver Cancer (ITALICA) Group [ ; Maurizio Biselli; Paolo Caraceni; Alessandro Cucchetti; Marco Domenicali; Fabio Piscaglia; Annagiulia Gramenzi; Alessandro Granito; Donatella Magalotti; Carla Serra; Giulia Negrini; Lucia Napoli; Veronica Salvatore; Francesca Benevento;]

Published
2017

192. Years of life that could be saved from prevention of hepatocellular carcinoma

Author

Andrea Costantino, Marcello Maida, Fabio Farinati, Laura Schiadà, Stefano Tamberi, Alessandro Moscatelli, Elena Rastrelli, Maria Chiaramonte, Paolo Poggio, Gianluca Svegliati Baroni, Matteo Renzulli, Fabio Piscaglia, Filomena Morisco, Paola Roselli, Roberto Virdone, Anna Maria Lalungo, Matteo Ravaioli, E.G. Giannini, Anna Chiara Dall’Aglio, Antonio Daniele Pinna, Elena Vavassori, Fabiana Marchetti, Eugenio Caturelli, Marco Domenicali, Calogero Cammà, Giulia Bosco, Carla Serra, Claudia Balsamo, Donatella Magalotti, Gian Ludovico Rapaccini, Valeria Mismas, S. Gemini, Stefano Olmi, Alberto Masotto, V. Feletti, Francesca Murer, Gaia Pellegatta, Maria Rosa Barcellona, A. Gazzola, Andrea Mega, Luigi Bolondi, Paolo Caraceni, Laura Bucci, Rita Golfieri, Annagiulia Gramenzi, Francesca Ciccarese, Rodolfo Sacco, Cristina Mosconi, Franco Borzio, Emanuele Rinninella, M. Di Marco, Alberta Cappelli, Marco Zoli, V. Vanin, Luisa Benvegnù, Mauro Bernardi, Emanuela Porro, Matteo Valerio, A. Pecorelli, Antonino Picciotto, Federica Mirici Cappa, Martina Felder, Elisabetta Biasini, Antonio Gasbarrini, Maurizio Biselli, Alessandro Cucchetti, Gabriele Missale, L. Venerandi, Serena Dell'Isola, Franco Trevisani, Elga Neri, Vincenzo Savarino, Maria Guarino, C. Pozzan, Giuseppe Cabibbo, F.G. Foschi, Giuseppe Francesco Stefanini, Arianna Lanzi, Andrea Affronti, Cucchetti, A, Trevisani, F, Bucci, L, Ravaioli, M, Farinati, F, Giannini, E. G, Ciccarese, F, Piscaglia, F, Rapaccini, G. L, Di Marco, M, Caturelli, E, Zoli, M, Borzio, F, Sacco, R, Maida, M, Felder, M, Morisco, Filomena, Gasbarrini, A, Gemini, S, Foschi, F. G, Missale, G, Masotto, A, Affronti, A, Bernardi, M, Pinna, A. D., Giannini, Eg, Rapaccini, Gl, Morisco, F, Foschi, Fg, Pinna, AD, Italian Liver Cancer (ITA.LI.CA.) Group, Bolondi, L, Biselli, M, Caraceni, P, Domenicali, M, Gramenzi, A., Cucchetti, A., Trevisani, F., Bucci, L., Ravaioli, M., Farinati, F., Giannini, E. G., Ciccarese, F., Piscaglia, F., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Maida, M., Felder, M., Morisco, F., Gasbarrini, A., Gemini, S., Foschi, F. G., Missale, G., Masotto, A., Affronti, A., Bernardi, M., Bolondi, L., Biselli, M., Caraceni, P., Domenicali, M., Magalotti, D., Pecorelli, A., Serra, C., Venerandi, L., Gazzola, A., Murer, F., Pozzan, C., Vanin, V., Del Poggio, P., Olmi, S., Balsamo, C., Vavassori, E., Benvegnu, L., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Bosco, G., Roselli, P., Dell'Isola, S., Lalungo, A. M., Rastrelli, E., Moscatelli, A., Pellegatta, G., Picciotto, A., Savarino, V., Barcellona, M. R., Camma, C., Cabibbo, G., Costantino, A., Virdone, R., Mega, A., Rinninella, E., Mismas, V., Dall'Aglio, A. C., Feletti, V., Lanzi, A., Cappa, F. M., Neri, E., Stefanini, G. F., Tamberi, S., Biasini, E., Porro, E., Guarino, M., Baroni, G. S., Schiada, L., Chiaramonte, M., Marchetti, F., and Valerio, M.

Subjects
Registrie, Male, Pediatrics, Databases, Factual, Hepatocellular carcinoma, 0302 clinical medicine, prevention, 80 and over, Secondary Prevention, Pharmacology (medical), Prospective Studies, Registries, Young adult, Prospective cohort study, Secondary prevention, Aged, 80 and over, education.field_of_study, Liver Neoplasms, Gastroenterology, Disease Management, Middle Aged, Primary Prevention, diagnosi, Italy, Liver Neoplasm, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Female, Human, Adult, medicine.medical_specialty, Carcinoma, Hepatocellular, Adolescent, Population, life expentancy, Milan criteria, 03 medical and health sciences, Databases, Young Adult, Life Expectancy, medicine, Humans, Aged, education, Factual, Hepatology, business.industry, Carcinoma, Settore MED/09 - MEDICINA INTERNA, Hepatocellular, medicine.disease, Surgery, Prospective Studie, Years of potential life lost, Life expectancy, business
Abstract

Summary Background Hepatocellular carcinoma (HCC) causes premature death and loss of life expectancy worldwide. Its primary and secondary prevention can result in a significant number of years of life saved. Aim To assess how many years of life are lost after HCC diagnosis. Methods Data from 5346 patients with first HCC diagnosis were used to estimate lifespan and number of years of life lost after tumour onset, using a semi-parametric extrapolation having as reference an age-, sex- and year-of-onset-matched population derived from national life tables. Results Between 1986 and 2014, HCC lead to an average of 11.5 years-of-life lost for each patient. The youngest age-quartile group (18–61 years) had the highest number of years-of-life lost, representing approximately 41% of the overall benefit obtainable from prevention. Advancements in HCC management have progressively reduced the number of years-of-life lost from 12.6 years in 1986–1999, to 10.7 in 2000–2006 and 7.4 years in 2007–2014. Currently, an HCC diagnosis when a single tumour

Published
2016

193. Autonomic nervous system dysregulation in irritable bowel syndrome

Author

Mara Malacarne, Beatrice Salvioli, A Malesci, G Pellegatta, F Pace, Daniela Lucini, M. Pagani, Salvioli B, Pellegatta G, Malacarne M, Pace F, Malesci A, Pagani M, and Lucini D

Subjects
Adult, Male, medicine.medical_specialty, Physiology, Gastroenterology, Irritable Bowel Syndrome, Standardized technique, Internal medicine, Heart rate, medicine, Humans, Spectral analysis, Inverse correlation, Fatigue, Irritable bowel syndrome, Endocrine and Autonomic Systems, business.industry, autonomic nervous system, irritable bowel syndrome, stress, Heart, Baroreflex, medicine.disease, Control subjects, Pathophysiology, Autonomic nervous system, Endocrinology, Autonomic Nervous System Diseases, Female, business, Stress, Psychological
Abstract

Background Autonomic nervous system (ANS) regulation may be altered in functional diseases, including irritable bowel syndrome (IBS), but published data are not clear to date. The aim of the study was to analyze ANS function in IBS subjects classified by Rome III criteria and healthy controls using standardized technique. Methods ANS activity was evaluated by autoregressive spectral analysis of RR interval and systolic arterial pressure variabilities, to obtain indices of sympatho-vagal modulation of the heart and of spontaneous cardiac baroreflex (α index). A symptom list was used to score 18 somatic complaints (score 0–180) (4SQ). Fatigue and stress were assessed through the use of a global scoring index (0–10). Key Results We enrolled 41 IBS subjects (29 F, age 40 ± 2 years) and 42 healthy matched controls. Heart rate was higher in IBS than control subjects (69 ± 2 vs 61 ± 1; p

Published
2015

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